FDA.reportPublic FDA data

STRADIS

Primary DI
M75240105RMSR11
Brand
STRADIS
Company
STRADIS MEDICAL, LLC
Model
40105RMS
Device description
CUSTOM DENTAL PAK SURGICAL PAK
Published
2017-05-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental
PWLOral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1
PWLOral Surgery TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M75240105RMSR11PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-962-2425SERVICE@STRADISHEALTHCARE.COM

Regulatory Flags#

DUNS number
174262477
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7525251811STRADIS525-1812017-04-01
M75257032650STRADIS HEALTHCARE570-32652023-01-17
M752682026NLXXXXX9STRADIS682-026NL2025-12-31
M7521697700Stradis Medical, LLC.1697702018-03-22
M752ACC25001Stradis Medical, LLC.ACC-25002018-01-29
M752ACC2500N1Stradis Medical, LLC.ACC-2500N2018-04-13
M752ACC25501Stradis Medical, LLC.ACC-25502018-01-29
M752DC1790911Stradis Medical, LLC.DC-17909-12018-05-22
M752DC51601Stradis Medical, LLC.DC-51602018-05-22
M752HCT6625TC0Stradis Medical, LLC.HCT6625TC2017-12-12
M752IM12350Stradis Medical, LLC.IM12352017-12-15
M752IM12510Stradis Medical, LLC.IM12512017-12-15
M752IM12600Stradis Medical, LLC.IM12602019-04-17
M752IMSEN101A0Stradis Medical, LLC.IM-SEN-101A2017-12-14
M752MAG30001Stradis Medical, LLC.MAG-30002018-05-30
M752ACC2550N1Stradis Medical, LLC.ACC-2550N2018-03-27
M752DC850A0Stradis Medical, LLC.DC-850A2018-04-23
M752HCT200BP0Stradis Medical, LLC.HCT200BP2017-12-07
M752HCT6057CP0Stradis Medical, LLC.HCT6057CP2017-12-12
M752HCT6186CP0Stradis Medical, LLCHCT6186CP2017-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
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J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
10198956208735CARDINAL HEALTHCardinal Health 200, LLCPWL2025-10-13
10198956170124CARDINAL HEALTHCardinal Health 200, LLCPWL2025-08-19
10198956094529CARDINAL HEALTHCardinal Health 200, LLCPWL2025-07-31
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
10197106600368CARDINAL HEALTHCardinal Health 200, LLCPWL2024-04-10
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
10304040166328Henry ScheinHENRY SCHEIN, INC.PWL2023-07-30
10304040166656Henry ScheinHENRY SCHEIN, INC.PWL2023-07-30
10304040167080Henry ScheinHENRY SCHEIN, INC.PWL2023-07-30
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
10197106089033CARDINAL HEALTHCardinal Health 200, LLCPWL2023-02-09
M75257029150STRADIS HEALTHCARESTRADIS MEDICAL, LLCPWL2023-01-17
08800000979113Hiossen Basic Instrument KITOsstem Implant Co., Ltd.PWL2022-12-08
08800000979120Hiossen Simple Instrument KITOsstem Implant Co., Ltd.PWL2022-12-08
10817417020098AsepticoASEPTICO, INC.EIA2022-12-08
10817417020135AsepticoASEPTICO, INC.EIA2022-12-08
10817417021309AsepticoASEPTICO, INC.EIA2022-12-08
10817417021507AsepticoASEPTICO, INC.EIA2022-12-08
10817417021514AsepticoASEPTICO, INC.EIA2022-12-08
10817417021521AsepticoASEPTICO, INC.EIA2022-12-08